GALPHARM 3-IN-1 ANTACID, SUPERDRUG 3-IN-1 ANTACID - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Galpharm 3-In-1 Antacid

Superdrug 3-In-1 Antacid

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Light Magnesium Carbonate Ph.Eur 175.5mg, Calcium

Carbonate Ph.Eur 400 mg, Stabilised Aluminium Hydroxide Ph.Eur 165mg

3. PHARMACEUTICAL FORM

Tablet

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the symptomatic relief of indigestion, excess acidity, flatulence, heartburn, dyspepsia and nausea.

4.2 Posology and method of administration

Adults and children aged 12 years and over:

One or two tablets to be sucked or chewed as required. Repeat whenever pain or discomfort is felt, up to a maximum of 16 tablets in any 24 hours.

No childrens dosage is recommended.

The normal adult dose should be taken by the elderly.

Oral administration only.

4.3 Contraindi­cations

Patients with hypophosphataemia, or on low phosphate diets, or receiving cardiac glycosides or with impaired renal function. Hypersensitivity to any of the ingredients.

4.4. Special Warnings and Special Precautions for Use

Label warnings.

Keep out of the sight and reach of children.

If symptoms persist, consult your doctor.

4.5 Interaction with other medicinal products and other forms of interaction

Changes in gastric acidity, such as that caused by the ingestion of antacids, can affect the rate and degree to which some concurrently administered medicines are absorbed. Due to the presence of calcium carbonate which acts as an antacid, a time-interval of 2 hours should be considered between 3-In-1 Antacid intake and the administration of other medicinal products.

Antacids of this type are known to decrease the absorption of concomitantly administered drugs due to adsorption, or delaying of gastric emptying or alkalinisation of gastric juice. However, the activity of cardiac glycosides such as digoxin may be increased (due to the presence of calcium).

4.6 Pregnancy and lactation

For 3-in-1 Antacid no clinical studies on exposed pregnancies are available.

Non-clinical studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal /foetal development, parturition or post natal development.

Caution should be exercised when prescribing to pregnant women and 3-in-1 Antacid should not be taken non-prescription without medical advice.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable Effects

Aluminium and calcium compounds can cause constipation but this effect is partially counteracted by the laxative effect of the magnesium salt.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms of Overdosage

Constipation or diarrhoea may occur depending on the susceptibility of the individual, also nausea and vomiting.

Treatment of Overdosage

Withdrawal of the product and normal supportive measures such as the use of rehydration fluid if diarrhoea is excessive.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Calcium and magnesium carbonates are quick-acting antacids which effectively neutralise the gastric acid but which are quickly exhausted, due to the chemical reaction being irreversible.

Stabilised aluminium hydroxide is a slower-acting antacid but its neutralisation action is reversible, providing a buffer activity which maintains a pH of 3–4. This is the pH region widely recognised as the optimum for antacid effect.

This triple combination therapy provides an immediate and long lasting antacid efficacy. In addition the laxative properties of the magnesium salt are counterbalanced by the constipating tendencies of the calcium and aluminium salts.

5.2 Pharmacokinetic properties

Not applicable. The product is formulated for local action in the gastrointesti­nal tract.

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.

6.1 List of excipients

Icing sugar Mannitol Saccharin sodium Maize starch Peppermint oil Magnesium stearate

6.2 Incompatibilities

None stated.

6.3 Shelf life

60 months. (Aluminium blister strip)

36 months (Aluminium/PVC/PVdC blister).

6.4 Special precautions for storage

None stated.

6.5 Nature and content of container

Aluminium foil strip containing tablets in individual pockets. 4 or 8 strips are contained in a cardboard carton. Pack sizes of 24 or 48 tablets.

Aluminium/PVC/PVdC blister strip containing tablets in individual pockets. Pack sizes of 24 or 48 tablets.

6.6 Instruction for use, handling and disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Galpharm Healthcare Limited

Wrafton

Braunton

Devon

EX33 2DL

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 16028/0050

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

06/02/2006